Off-label info a risk in schizophrenia drug details: study

Psychiatrists asked to recall the tenor of discussions they had with industry sales people regarding the newest class of schizophrenia drugs said such conversations tended more toward on-label indications than the off-label kind. Nonetheless, the clinicians' independence may have been compromised, researchers wrote this month in the journal Psychiatric Services, as some reps verbally referred to off-label uses.

Researchers from Yale University, comparing statements heard by more than 600 psychiatrists, found that the most common statements were consistent with package-insert (PI) information. That came as no surprise. Claims supported by the label included decreased risk of extrapyramidal symptoms (79%) and greater symptom reduction than placebo (78%).

“Perhaps the most striking observation,” they wrote, was that all statements, even the less frequently heard, off-label ones like better symptom control than first-generation antipsychotics (36%), were sometimes conveyed directly through verbal communication, rather than through indirect means like patient handouts or sponsored talks.

Also of note: doctors, all of whom worked at Department of Veterans Affairs medical centers, said the risk of diabetes was often conveyed solely through indirect means, despite being supported by the label. Eli Lilly, maker of next-generation antipsychotic Zyprexa, recently underscored that side effect in its drug label.

Prescribers of drugs for treating schizophrenia are among the most prized by pharma firms, especially by marketers of atypical antipsychotics such as Lilly, Johnson & Johnson, which makes Risperdal, and AstraZeneca, which touts Seroquel.

Little is known about detailing of such drugs, even though the products represented the most costly group provided by Medicaid at $3 billion. In 2005, about $10 billion was spent overall on second-generation antipsychotics, authors wrote.

The package insert forms the basis of drug advertising and of what reps are allowed to say when speaking with clinicians about their company's products. Even though uses endorsed by the PI were most frequently heard by study respondents, psychiatrists asked for their beliefs endorsed at least some of the off-label statements.

This prompted researchers to conclude that off-label information could pose a problem: “The self-reported independence of practitioners may not be nearly as great as they believe it to be.”